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Zonegran for the Treatment of Weight Gain Associated With Psychotropic Medication Use: A Placebo-Controlled Trial (Zonegran)

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ClinicalTrials.gov Identifier: NCT00203450
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : September 3, 2012
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date September 3, 2012
Study Start Date  ICMJE May 2003
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
The primary objective of this study is to compare the efficacy of zonisamide (Zonegran; 100mg - 400mg/day) and placebo as an adjunctive agent on lowering weight in subjects who have a body mass index (BMI) of >25 and are on a psychotropic medication with
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2012)
NThe weight loss in patients treated with Zonisamide will be significantly greater than those treated with placebo.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zonegran for the Treatment of Weight Gain Associated With Psychotropic Medication Use: A Placebo-Controlled Trial
Official Title  ICMJE Zonegran for the Treatment of Weight Gain Associated With Psychotropic Medication Use: A Placebo-Controlled Trial
Brief Summary The primary objective of this study is to compare the efficacy of zonisamide (Zonegran; 100mg - 400mg/day) and placebo as an adjunctive agent on lowering weight in subjects who have a body mass index (BMI) of >25 and are on a psychotropic medication with a known side effect of weight gain.
Detailed Description After the screening period, patients fulfilling entrance criteria will be randomized to 100mg of zonisamide or placebo in a 2:1 ratio respectively. Patients will be assessed at baseline and on Weeks 2, 4, 8, 12, and 16-post randomization for weight, side effects, and symptoms. Symptoms will be assessed by the Young Mania Rating Scale (YMRS), Brief Psychiatric Rating Scale (BPRS), Hamilton Depression Rating Scale (HAMD), Hamilton Rating Scale for Anxiety (HARS), and Self-report measures of general health and mental status at baseline, weeks 2, 4, 8, 12,and 16. At the conclusion of the study, patients will be tapered from the study medication and will return to their primary provider for continued treatment of their psychiatric condition.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Drug: Zonegran
    zonisamide
    Other Name: zonisamide
  • Drug: Placebo
    Placebo pill
    Other Name: placebo pill
Study Arms  ICMJE
  • Experimental: Zonegran
    Zonegran
    Intervention: Drug: Zonegran
  • Placebo Comparator: Placebo
    Placebo pill
    Intervention: Drug: Placebo
Publications * Appolinario JC, Bueno JR, Coutinho W. Psychotropic drugs in the treatment of obesity: what promise? CNS Drugs. 2004;18(10):629-51. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 30, 2012)
20
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
60
Actual Study Completion Date  ICMJE March 2006
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Are men or women, between the ages of 19 and 65, inclusive
  • Have a diagnosis of any type of bipolar disorder or any type of psychotic disorder based on structured diagnostic interview (MINI).
  • Are currently outpatients or inpatients and taking a neuroleptic or mood stabilizer medication (listed below) for the past 6 months, and on a stable dose for the past 2 months.
  • Have a body mass index > 25.
  • No substance use disorder in the past 2 months (except for nicotine or caffeine).
  • Agree to not become pregnant during the study and agree to use an adequate method of birth control during the study such as a barrier method, hormonal contraceptive, or surgical sterilization (females only). All women of childbearing potential must have a negative pregnancy test before beginning study medication.
  • Are able to swallow the capsules whole
  • Are willing and able to follow Investigator instructions and study procedures, and report adverse events
  • Not currently actively suicidal or homicidal.
  • No use of topiramate within the last 6 months.
  • No medical contraindication to the use of zonisamide.

List of medications for inclusion criterion #3:

All conventional neuroleptics. All atypical neuroleptics except aripiprazole or ziprasidone. All forms of valproate. All forms of lithium. All forms of carbamazepine.

Exclusion Criteria:

  • Clinically significant renal or hepatic disease.
  • History of acute intermittent porphyria, glucose-6phosphate dehydrogenase deficiency or hemolytic anemia.
  • Allergy to zonisamide or sulfonamides.
  • Have clinically unstable cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine, or other systemic disease
  • Have laboratory test results that, in the opinion of the Investigator, are clinically significant abnormalities
  • Require treatment with any medication (e.g., carbonic anhydrase inhibitors) that might interact adversely with, or obscure, the action of the study drug
  • Are pregnant or lactating (females only)
  • Have a history of nephrolithiasis
  • Refuse to give informed consent
  • Have previously enrolled in this study or previously been treated with zonisamide
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00203450
Other Study ID Numbers  ICMJE TREAC Zonegran for Weight Loss
TREAC Zonegran for Weight Loss
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation
Study Sponsor  ICMJE Tuscaloosa Research & Education Advancement Corporation
Collaborators  ICMJE Eisai Inc.
Investigators  ICMJE
Principal Investigator: Lori L Davis, MD Tuscaloosa Veterans Affairs Medical Center
PRS Account Tuscaloosa Research & Education Advancement Corporation
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP